With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Sunday, March 29, 2015

Randy Mills' chart last week on changes coming as a result of CIRM 2.0

On New Year’s Eve, the California stem cell agency and its
relatively new president, Randy Mills, kicked off a radical and fresh way to
hand out money to researchers and speed development of therapies.

Today, nearly three months later, the agency is still
wrestling with some key issues, including virtual termination of its old, $500
million loan program.

Nonetheless, at a meeting last week in Berkeley, the governing
board of the agency did put behind it many aspects of implementation of what it
calls CIRM 2.0, a term drawn from its official name, the California
Institute for Regenerative Medicine(CIRM).

Approved were new rules involving administration of grants
and beefed up oversight of the research -- with the agency as an ever more
engaged partner with researchers, some of whom may not care for more suggestions from the back seat.

Background checks will be required on recipients. Budgets
that are out of whack will not even be submitted to agency’s application
reviewers. Much paperwork will be eliminated. The out-of-state researchers who
approve the grants will now also scrutinize progress and make recommendations. That’s
on top of clinical advisory panels that will be created to monitor research
progress on a quarterly basis. Researchers will be encouraged to save money and will have more freedom to spend surplus cash. (For more details, see here and here.)

The goal says Mills, who has been in place only since last
May, is to send checks to researcher 120 days after they submit an application
instead of the previous average of 22 months. New clinical stage projects
are now being accepted every month instead of only once or twice a year.

Most of the CIRM 2.0 matters are much too granular to impress the public, which really only cares about production of useful therapies. But if Mills is successful, it will likely mean speedier development of the treatments that were promised 10 years ago ago when voters created the stem cell agency. Researchers and stem cell firms, as opposed to the general public, need to pay close attention, however, to the details, which can mean millions of dollars for them.

Another stem cell filip is coming up this spring: the agency's strategic plan, which appears ready to be revised as a CIRM 2.0 document. Mills avows his continued support for basic research, strongly favored by board members from academia and research institutions. But heavy pressure exists to bring a product to market quickly or much closer to market. Without such a demonstration, the agency will find it tough to secure additional funding after 2020, the latest estimate when its cash will run out.

Still hanging out there are the details of what will be left
of the agency’s once ambitious, seven-year-old loan program, which was a favorite of the agency’s
first chairman, Robert Klein.

Only five loans were made. Only two are still active. In a
memo to the board, Mills said the program was “overly complex, administratively
burdensome, and, as reflected in the number of loans issued, it does not appear
to be attractive to industry.”

He told the board last week that small companies balk at the loans because they do not want the debt on their balance sheets. Grants, however, carry royalty requirements that companies also dislike.

Mills said,

"If we can't make it better, maybe it shouldn't exist."

The board’s intellectual property committee was scheduled to
act on a new loan policy in January but that meeting was cancelled with no
public explanation. Again this month, a meeting was scheduled but postponed
with no immediate explanation. The link to the proposed policy was removed from
the CIRM Web site, although the document can be found here.

CIRM spokesman

Kevin McCormack, in response to a question from the California
Stem Cell Report, said,

“The meeting was postponed so we could work on the proposal
some more before bringing it to the subcommittee. The document was removed from
the Web site because it was actually the wrong document. It was an earlier,
outdated version of the proposal and didn't reflect many of the changes that
were made.”

Last week's action directly involved only the first stage of CIRM 2.0, but Mills plans to extend the process to the entire portfolio, making adjustments as necessary. The rules are officially interim. The state’s official regulation adoption process is much lengthier and will provide more opportunity for the public to comment.

Mills has told the board that implementation of his changes will
not necessarily be smooth. He also said the effort is likely to be modified as
CIRM 2.0 progresses.

CIRM chart on status of CIRM 2.0 applications

Mills has now scheduled the first, closed-door review
session for a CIRM 2.0 application, one of two received in January. The 90-minute telephonic meeting is set for tomorrow. The second
application from January was sent back to the applicant for re-working. The
agency received two CIRM 2.0 applications in February. One was sent back to the applicant. The other is expected to be reviewed and scored April 27.

More CIRM 2.0 applications are expected at the end of this month, next Tuesday.

The public can address tomorrow's meeting from CIRM's headquarters in San Francisco during the public portion of the session. As usual, however, the name of the researcher and the target of the research are being withheld from the public.

See here, here and here for the text of key documents on CIRM
2.0 approved at last week's meeting.

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.